In general, there are two types of cardiovascular abnormalities tests: a one-time recording during a few seconds and a long-term monitoring which can be performed during regular daily activities or as a round-the-clock monitoring in patients with serious medical disturbances. An example of a one-time recording is an electrocardiogram (ECG) test. However ECG test is not sufficient comprehensive because it tests only a brief period of time, and therefore can detect only a part of cardiovascular abnormalities.
A prime example of long-term monitoring system is a 24-hour cardiovascular monitoring Holter system which is widely used in the prior art for diagnosing cardiac abnormalities. Currently used Holter recording devices use an analogue or digital recording technique. Data recorded by such a holter was initially analyzed by a medical professional, which amounts to many hours of expensive manual labor. One such basic Holter ECG system disclosed by Elliott in U.S. Pat. No. 5,398,183, another one by Thornton in U.S. Pat. No. 5,036,856.
As a next development of holter technology, computerized data analysis was introduced. Usually, in current digital Holter systems, processing of the data consists of computerized data scanning to receive the preliminary diagnosis with subsequent manual verification by a medical professional.
Such Holter system had been developed by several companies worldwide:                Burdick Vision holters by CardiacScience Inc, a US company;        FM Series holters by a Japanese company Fukuda;        DL Series holters by Braemar Inc, another US company;        H-Scribe holter by Mortara, another US company;        DR 180 holter by NEMon;        Reveala by Nasan Medical, an Indian company; to name a few.        
Holters mentioned above provide mainly data recording.
Lately, there have been further developments in the holters industry. A number of modern holters are now equipped with data analysis software. An example of such a holter is a Trillium 3000 by Forest Medical. In this holter all cardiological data is recorded over the 24 hours period, and at the end of the 24 hours period a report is generated using data analysis tool. This report is further printed and the printed report is presented to the physician for his review. Another example of a holter with analyzing capabilities is the one presented by the Epicardia Holter Systems, where after finishing data recording, the technician can scan the recorder data and generate a report on events detected.
An example of Holter system with analysis capabilities was presented by Gallant in U.S. Pat. No. 5,433,209 named “Recorder unit for ambulatory ECG monitoring system”.
As a further development of holter systems, there are products that provide transfer of cardiological data recorded through the Internet or through the wireless device to the clinic. I.e., data is recorded for, say, 24 hours and then, instead of visiting the clinic, the patient has to connect to the Internet at his home computer and send the data to the medical center through the Internet. Alternatively, in other products the patient has to send the data from his holter to the medical center through wireless device. In both cases above, the medical diagnosis and, consequently, alert on cardiovascular abnormality is in the clinic and not in real-time. An example of such a holter is a Vision Premier developed by Burdick company, which includes connectivity between the holter and various information systems, including the suite of HeartCentrix web data management solutions. An example of holter data transmittance through the wireless system is presented by HealthPAL device from MedApps company that automatically collects data from compatible, off-the-shelf, medical monitors using a smart cable or wirelessly via Bluetooth. The data is then transmitted using embedded M2M (GSM and CDMA) cellular chip technology to be received by HealthCOM, MedApps' full-featured, web-based portal for health care providers.
U.S. Pat. No. 6,701,184 titled “Virtual Holter” by Henkin describes such holter that provides “ECG Holter data scanning, processing, and analyzing system by way of obtaining a Holter recording in a conventional manner, then downloading that analog or digital data to a PC, then going online through the PC by way of an ISP, such as DSL, capable of large data transfer, through a USB to tie into a URL web address for a Central Computing Facility . . . ”. One further similar system disclosed in U.S. Pat. No. 7,353,179 titled “System and method for handling the acquisition and analysis of medical data over a network” by Ott. Ott describes a system that receives and controls Holter data from remote computers associated with the patients.
An example of Holter ECG system that uses a cellular architecture to monitor and to transfer ECG signals via cellular network presented by Flach in U.S. Pat. No. 6,773,396 named “Cellular architecture and data transfer methods for real time patient monitoring within medical facilities”. One more example of a similar system presented by Gerder in U.S. Pat. No. 7,301,452 titled “Care device with wireless data communication”. US 20090115628, 20090112769 and 20080224852 by Dicks describe a system configured to wirelessly receive data from a medical device using the medical device transceiver and transmit the data to an intermediary device using the data relay transceiver.
US patent application 20060100530 by Kliot titled “Systems and methods for non-invasive detection and monitoring of cardiac and blood parameters” discloses a “Method and system for long term monitoring of one or more physiological parameters such as respiration, heart rate, body temperature, electrical heart activity, blood oxygenation, blood flow velocity, blood pressure, intracranial pressure, the presence of emboli in the blood stream and electrical brain activity are provided.” Kliot in his system actually provides a possibility of alert and “localization capabilities incorporating VHF, GPS, satellite and/or triangulation location systems,” but his system is limited to physiological parameters such as respiration, heart rate, body temperature, etc. and is not a holter system. Actually, Kliot mentions holters in his prior art paragraphs as: “Although Holter and cardiac event monitors are being used in attempts to diagnose and monitor various cardiac irregularities that are asymptomatic or infrequently experienced, their limited data storage and analysis capabilities have reduced their application for wider ranging diagnostic and monitoring applications. The success rate is rather low with these devices, since the Holter monitor seldom captures rare events in the typical, relatively short-term recording period and event monitor is patient-triggered and user dependent. These systems could be improved with more substantial recording and data storage capability and better analytical systems. The Holter and cardiac event monitors also are typically operated as stand-alone devices and are not interfaced with other devices collecting clinically useful patient data. Nonetheless, Holter and cardiac event monitoring are the only longer-term cardiac event monitoring systems presently available.”
As a most sophisticated development of holters, there are a few that provide cardiovascular data analysis of several major cardiological diseases and sent the data analyzed through wireless network. The most advanced of such a product is a Cardionet which presents the “Mobile Cardiac Outpatient Telemetry” product with real time analysis, automatic arrhythmia detection and wireless ECG transmission.
Clinical trial management is a second major aspect of the invention.
Effective clinical trial management systems relies on a means of real-time collection of data and performance measures to be able to react instantly to the changes in performance of medicine or treatment in the clinical trial participant, which is very important when relevant information belongs to the clinical trial where participant location may be very diverse geographically. This is especially true in clinical trials of new medicines as clinical evaluations of new pharmaceuticals in particular involve numerous evaluations at different stages of development that often involve many sites spread throughout different countries and time zones.
Currently, clinical trial data mainly manually recorded on paper or entered manually via a keyboard to the computer. Alternatively, “paperless” data may be entered directly into a computer at a remote site, in either manual or automated way. With advancements in computer science there had been some advancement in clinical trials field. There are a number of prior art citations that disclose real-time clinical trial systems. One such example is provided by El Eman in US patent application 20070265881. El Eman discloses a system where real-time interactive patient form is introduced. Clinical trial participants insert data related to the clinical trial via the XML web-based form and they can transfer it via the web to the centralized database of a clinical trial. Another similar system is disclosed in US patent application 20050055241 by Horstmann wherein a real-time clinical trial study documentation is provided and where a change to the documentation by an authorized user is made available in real time to one or more other authorized users for tasks relating to the clinical trial study documentation. Another example of a similar system was disclosed in a US patent application 20050038692 by Kane titled “System and method for facilitating centralized candidate selection and monitoring subject participation in clinical trial studies” wherein centralized remote ratings of subjects in clinical trial studies are introduced to determine whether a candidate is a qualified subject for the clinical trial and/or in the actual assessment, or information collection, phase of the clinical trial. US patent application 20040093240 by Shah provides real-time clinical trial status monitoring at definable intervals and it is another variant of the prior art type above.
As a further development in the clinical trials industry, currently there are a few prior art citations where wireless data communication has been introduced. For one, US 20080228057 titled “Method and system for controlling data information between two portable apparatuses” by Graskov discloses a method and system of controlling data information between two portable handheld apparatuses where information gathered throughout the clinical trial could be transferred wirelessly, and in particular “lipid monitor, a pulse monitor, a lancet device, a storage container, and a blood glucose monitor (BGM).” Unlike our disclosed invention, no cardiological data is introduced here and no real-time and adaptive clinical trial features could be seen here. Another such system is presented in US 20070156459 by McMahon that discloses a system for conducting a clinical trial of a pharmaceutical substance on a plurality of trial participants that includes a central database and the remote computers being configured to receive predetermined trial data from one or more trial participants. Yet another similar system is presented in US 20080021341 titled Methods and Systems for Facilitating Clinical Trials by Harris that involves a clinical trial for experimental therapies rather than for the pharmaceutical substance.
More sophisticated approach is presented in several prior art patent applications wherein the data is collected wirelessly. One such prior art invention is US patent application 20080270181 titled “Method and system for collection, validation, and reporting of data and meta-data in conducting adaptive clinical trials” by Rosenberg. In 20080270181 Rosenberg describes a system for centrally managing data in an adaptive clinical trial or other adaptive process that is conducted at a plurality of geographically remote sites. Rosenberg discloses a system that collects data from remote sites in a clinical trial by the means of internet, telephone, wireless system, RSS feed or Atom feed. The system also provides interaction between central and remote sites to manage and resolve data discrepancies. The invention provides some improvement on the abovementioned since it provides some ability to collect and process various forms of data in order to adjust actions related to the clinical trial but it still maintains the shortcomings of the prior art above. The data is not collected in real-time but rather collected through the patient's visit to the remote clinical site and then the data could be transmitted by internet, wirelessly, etc. Still, unlike our invention, no real-time and personalized cardiological data analysis, response and adaptation are made.
An additional element of our invention is an alert-triggered permanent blood pressure measurement system.
Currently blood pressure measurement is done mainly when the patient is visiting the physician or using a regular self-measurement home blood pressure measurement device. Those measurements methods required an improvement since blood pressure results could vary during several one-time measurements. Some 25% of the patients have higher blood pressure when visiting the physician, for example. Accordingly, ambulatory blood pressure monitors systems have been created, one of those by a German manufacturer Ergoline named Ergoscan 24, another is by Chinese manufacturer Contectmed “CMS06C ABPM Ambulatory Blood Pressure Monitoring System”.
Additionally, there are a number of prior art inventions on the matter of ambulatory blood pressure systems and devices known in the prior art. For one, there is a U.S. Pat. No. 7,429,245 by Whitaker titled “Motion management in a fast blood pressure measurement device”. That invention discloses an apparatus and a method for measuring the blood pressure of a vertebrate subject that uses an inflatable chamber with a sensor to detect signals indicative of a blood pressure of the subject during an inflation interval of the inflatable chamber. If secondary motion or artifact signals are detected, the apparatus and method determine whether the secondary signals are below a predetermined value, and if so, complete the measurement.
Another U.S. Pat. No. 5,447,161 discloses: “a process and measurement device for noninvasive determination of venous and arterial blood pressure in the arteries of the human body, particularly in the finger and toes. An occlusion band and peripherally thereto a sensor for the detection of changes in the blood volume during the pressure-buildup procedure is attached in these measurement areas”.
Another U.S. Pat. No. 6,632,181 titled “Rapid non-invasive blood pressure measuring device” by Flaherty discloses a blood pressure ambulatory measurement device that works by supplying an external pressure to a portion of an artery and where the external pressure is preferably between the systolic and diastolic pressure.